A Retrospective Study to Assess the Impact of the Use of Interferon in Patients With Chronic Hepatitis C (DECISION)
NCT ID: NCT01280656
Last Updated: 2016-11-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
660 participants
OBSERVATIONAL
2010-01-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Conventional Interferon Plus Ribavirin
Eligible participants who will receive conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Conventional Interferon
Conventional interferon according to the standard of care and aligned with the local prescription instructions
Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2a Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2a
Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2b Plus Ribavirin
Eligible participants who will receive peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions will be observed during treatment period (48 weeks) and follow up period (24 weeks).
Peginterferon Alfa-2b
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Interventions
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Conventional Interferon
Conventional interferon according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2a
Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
Peginterferon Alfa-2b
Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
Ribavirin
Ribavirin according to the standard of care and aligned with the local prescription instructions
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of hepatitis C
* Assessment of viral load prior to treatment (mandatory for genotype 1 only)
* Liver biopsy
* Co-morbidities data
* Use of interferon (pegylated or conventional) and ribavirin to treat hepatitis C infection genotype 2 and 3 and pegylated interferon plus ribavirin to treat hepatitis C infection genotype 1
* Above mentioned treatment started between 01-Sep-2007 and 31-Aug-2008
Exclusion Criteria
* Co-infection with hepatitis B virus
* Presence of hepatocarcinoma
* Patients submitted to hemodialysis
* Organ transplant patients
18 Years
70 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Rio Branco, Acre, Brazil
Manaus, Amazonas, Brazil
Vitória, Espírito Santo, Brazil
Salvador, Estado de Bahia, Brazil
Goiânia, Goiás, Brazil
São Luís, Maranhão, Brazil
Campo Grande - MS, Mato Grosso do Sul, Brazil
Pouso Alegre, Minas Gerais, Brazil
Uberaba, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Curitiba, Paraná, Brazil
Belém, Pará, Brazil
Recife, Pernambuco, Brazil
Recife, Pernambuco, Brazil
Niterói, Rio de Janeiro, Brazil
Nova Iguaçu, Rio de Janeiro, Brazil
Rio de Janeiro, Rio de Janeiro, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Rio Grande, Rio Grande do Sul, Brazil
Porto Velho, Rondônia, Brazil
Sao Jose Do Rio Preto, Santa Catarina, Brazil
Aracaju, Sergipe, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Santo André, São Paulo, Brazil
Santos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Countries
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Other Identifiers
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ML22995
Identifier Type: -
Identifier Source: org_study_id